Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer

Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer

This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Intermittent hypoxia intervention

Detailed Description

The hypoxic adaptive response is a form of acquired tolerance that occurs by activating internal cellular protective mechanisms and enhancing immune function.This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia. This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia.

Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused by hypoxia. Intermittent hypoxia has been shown in our team's work to effectively inhibit colorectal cancer tumor progression in mice by enhancing immune cell function. This study aims to explore the safety and efficacy of IH in patients with colorectal cancer using a non-randomized self-controlled trial.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Wang, M.D.; Phone Number: +86-13581567815; Email: wilma0106@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Xunming Ji, M.D.;Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with colorectal cancer between ages of 18 and 65 years.
• Colorectal cancer stage Ⅰ,Ⅱ.
• Subjects or their legally authorized representative can provide informed consent.

Exclusion Criteria:

• History of cardiovascular, cerebrovascular, dermatological, and hematological diseases.
• History of pulmonary, hepatic, kidney, dermatologic and hematologic diseases.
• History of pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
• History of substance abuse.
• Participating in other drug or medical device studies.
• History of organ transplantation, including allogeneic stem cell and immune cell transplantation.
• Recent severe infection within 4 weeks.
• Received cancer treatment, including chemotherapy and radiotherapy, within 4 weeks.
• Underwent major surgery within 28 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients; Participants will receive 14 times intermittent hypoxia (oxygen concentration: 13%) intervention before the surgery.	Other: Intermittent hypoxia intervention; The intermittent hypoxia protocol refers to 6 cycles of 10 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse reactions	Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.	During the 7-day treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Markers	Blood tumor markers will be detected by the immunochemiluminescence method.	The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Tumor Change	Tumor Change will be detected by tumor cell HIF-1α and HIF-2α through immunohistochemistry.	The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Cytokines	Cytokines will be detected by immune-related cytokines in peripheral blood.	The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Symptoms	It is evaluated by completing the follow-up form.	The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery
Immune Cell Infiltration	Immune Cell Infiltration will be detected by observation of immune cell infiltration in tumor tissue.	The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Signs and Symptoms, Respiratory; Colorectal Neoplasms; Hypoxia
• Other Study ID Numbers: IH-CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No